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Amniotic Membrane in Carpal Tunnel Syndrome

NCT ID: NCT04075357

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-08-28

Brief Summary

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Carpal Tunnel Syndrome (CTS) is the most frequent mononeuropathy. CTS is more frequent in females than in males, it has been associated to work activities, hormone exposure and obesity. Although its primary treatment is conservative, there is strong evidence that patients who retard surgery are more prone to develop worse outcomes. Surgery to treat CTS consists in liberating carpal tunnel in order to ameliorate median nerve symptoms; however, more than 20% of patients who undergo surgery have recurrent CTS (RCTS). RCTS is due to a fibrotic process in the site of the surgery. Amniotic membrane (AM) is the inner layer of the placenta which has been used to treat different pathologies. AM transplantation (AMT) has demonstrated to significantly inhibit inflammation and fibrosis. Therefore, the aim of the present study was to determine the effect of AMT in CTS surgery. The present is a randomized, open labeled, controlled clinical study. The investigators included patients with recent diagnosis of CTS and divided into two groups. The experimental group received AMT concomitantly with conventional surgery; whilst, the control group received only the conventional surgery. Clinical status of patients measured with the BCTQ questionaire was the main outcome. Both groups showed similar BCTQ punctuation at the beginning of the study. However, the results of the experimental group were significantly better than those from the control group through time, until the finish of the study. None of the patients presented complications or adverse effects related to the AMT. These results indicate that AMT is a secure and suitable treatment for CTS presenting better clinical outcomes at one-year follow-up.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Keywords

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Amniotic membrane transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

The patients underwent conventional CTS surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental

The patients underwent conventional CTS surgery and transplantation of amniotic membrane

Group Type EXPERIMENTAL

Amniotic membrane transplantation

Intervention Type OTHER

Amniotic membrane was located over median nerve during surgery of CTS, prior of closing.

Interventions

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Amniotic membrane transplantation

Amniotic membrane was located over median nerve during surgery of CTS, prior of closing.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with recent CTS diagnosis
* Patients that undergo CTS surgery
* Patients that accept to participate in the study
* Patients that sign informed consent

Exclusion Criteria

* Patients with recurrent CTS diagnosis;
* Patients with concomitant hand/arm comorbidities
* Patients with any systemic disease that comprises muscles and bones
* Collagenopathies
* Systemic lupus erythematosus
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Council of Science and Technology, Mexico

OTHER

Sponsor Role collaborator

Instituto de Oftalmología Fundación Conde de Valenciana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Instituto de Oftalmología

Mexico City, , Mexico

Site Status

Countries

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Mexico

References

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Buentello-Volante B, Molina-Medinilla M, Aguayo-Flores E, Magana-Guerrero FS, Garfias Y. Comparison of amniotic membrane transplantation and carpal tunnel syndrome release surgery (CTRS) and CTRS alone: Clinical outcomes at 1-year follow-up. J Tissue Eng Regen Med. 2020 May;14(5):714-722. doi: 10.1002/term.3033. Epub 2020 Mar 24.

Reference Type DERIVED
PMID: 32174033 (View on PubMed)

Other Identifiers

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CEI-2016/10/04

Identifier Type: -

Identifier Source: org_study_id